After India, European Union to probe Wanbury Pharma for illegal export

EMA’s involvement in the case comes two weeks after the Drugs Controller General of India gave an export certificate to Wanbury to supply drugs to the European Union.DIVYA RAJAGOPAL | ET Bureau | October 31, 2016, 08:06 IST

The Mumbai-based drug maker was served a show cause notice by the Maharashtra Food and Drug Administration last week for alleged illegal re-labelling of its drugs to be exported to Brazil, Mexico, Bangladesh and Pakistan.

“The European Medicines Agency is currently investigating the allegations (by the local FDA), this is all we can say for now.” said Rebecca Harding, from Media and Public Service division of the EMA, in an email to ET.

EMA’s involvement in the case comes two weeks after the Drugs Controller General of India gave an export certificate to Wanbury to supply drugs to the European Union. The export certificate issued on October 18 entails Wanbury give a legal undertaking about inspection/investigation reports of the Indian regulatory authority, including show cause notices, suspensions, cancellations among others.

According to the rules of the EU, active pharmaceutical ingredients (APIs) shipped for medicinal products need to have a “written certification” from competent local enforcement agencies confirming compliance with good manufacturing practices.

It is not clear if the drug controller has reviewed its decision to grant the export certificate to the company. In an email response to ET Drug Controller earlier said that the decision to grant export license was made, based on a June 24 inspection conducted by the regulator’s West Zonal office in Mumbai.

“Written confirmation is issued by the CDSCO based on the manufacturing facility compliance to European Union GMP,” CDSCO’s international cell said last week.

“As per the Drugs & Cosmetics Act, 1940, licences for manufacturing, sale and distribution of drugs are granted by state authorities and all enforcement action with regard to manufacture of any spurious, NSQ (substandard), adulterated and misbranded drugs is taken by such authorities,” the regulator had said.

The Maharashtra FDA’s preliminary investigation found the drug maker had export orders of 650 metric tonnes per month, but only had capacity to manufacture 300 metric tonnes.

To overcome this shortage, Wanbury outsourced the manufacturing of metformin to a company called Pharmaceutical Products of India (PPIL).

“Wanbury just removed the label of PPIL that did not have any export licence, and without doing any processing on the product, obtained from it, and merely stuck its own label — and exported it”, FDA found in its initial investigation.

Both PPIL and Wanbury were in cahoots that was mutually beneficial, but it could have led to disastrous effects on the drug exports of our country as the Drugs and Cosmetics Act treats such exported products as spurious, the FDA explained.

The investigation by the local regulator also revealed that records for manufacturing and testing were not maintained by PPIL and books were fudged to show the drugs as being made by Wanbury.

Wanbury did not respond to the email query sent by ET till press time. In a notice to stock exchanges on October 24, the company said that all its exports were done legally and that the Pharmaceutical Products India plant at Tarapur — the third-party facility — was the lone licensee manufacturer for the company.

In FY15-16, Wanbury recorded revenues of Rs 424 crore, another filing to the stock exchanges said.

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